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Covid19 kevzara

Sanofi/Regeneron End Kevzara Development For COVID-19

Sanofi/Regeneron Pharmaceuticals, Inc.'s interleukin-6 inhibitor Kevzara (sarilumab) will not be developed further for treatment of hospitalized COVID-19 patients after a Phase III trial in severely and critically ill patients failed to meet either its primary endpoint or key secondary endpoint.

The disappointing news isn't a surprise at this point, coming after Kevzara previously didn’t show a benefit in patients requiring mechanical ventilation in Phase III, and after another IL-6 inhibitor – Roche Holding AGs Actemra (tocilizumab) – also failed a Phase III trial in hospitalized COVID-19 patients. (Also see "Coronavirus Update: Moderna Hold Up, Sanofi and Regeneron's Kevzara Fails In Phase III" - Scrip, 3 Jul, 2020.) 

The trial in severe and critical patients, conducted outside the US and led by Sanofi, was continued after the Regeneron-led, US-based trial in ventilated patients was stopped on the recommendation of an independent data monitoring committee. (Also see "Coronavirus Update: Roche's Actemra Fails In Phase III COVID Study" - Scrip, 29 Jul, 2020.)

The ex-US trial randomized 420 patients to 200mg or 400mg doses of Kevzara or placebo on top of usual hospital care. Numerical trends were observed toward a decrease in duration of hospital stay as well as an acceleration in time to improved clinical outcomes based on a seven-point scale, but those were not statistically significant.

A trend toward reduction of mortality also was seen in the critical patient group, but not observed in the severe patient groups. Time to discharge was shortened by two to three days in patients treated with Kevzara within the first two weeks of treatment, but that was statistically non-significant.

Both Sanofi and Regeneron are pursuing other potentially preventative options for COVID-19, including Regeneron's antibody cocktail in Phase III.  Also, Sanofi has a vaccine program, partnered with GlaxoSmithKline plc

Regeneron Hiring As It Shuffles Biologics Manufacturing

To ramp up supply of the antibody combination REGN-COV2 for the potential treatment and prevention of COVID-19 infection, Regeneron is moving some of its other biologics manufacturing to Limerick, Ireland. The company announced on 27 August that it will add 400 new jobs to support the production of Regeneron's medicines, which will bring the total headcount to 1,400 at the Limerick campus.

Regeneron has invested more than $1bn since 2014 to build the largest bulk biologics production facility in the country, according to the company

The production buildout has come faster than expected, however. "In order to make space in our New York facilities to accommodate our COVID-19 efforts, we needed to ramp up capacity here in Limerick," exec VP and general manager of Industrial Operations and Product Supply Dan Van Plew said in a statement.

Regeneron's antibody cocktail is being tested in Phase III in the preventative setting and in Phase II/III as a COVID-19 treatment. The company recently announced it is partnering with Roche to develop, manufacture and commercialize the product. (Also see "Roche Signs Up To Be Regeneron’s Global Partner For COVID Antibody" - Scrip, 19 Aug, 2020.)

Japan AMED Support For Daiichi, VLP Therapeutics Vaccines

Japan’s government, through the Agency for Medical Research and Development (AMED), has selected coronavirus vaccine candidates being developed by Daiichi Sankyo Co., Ltd. and VLP Therapeutics, LLC. for financial support, in the second round of funding under the agency’s dedicated support program designed to speed development.

Set to receive the new funds are Daiichi’s mRNA vaccine DS-5670 and a self-amplifying RNA vector (replicon) vaccine being developed locally by VLP’s Japanese subsidiary. DS-5670 uses novel nucleic acid delivery technology discovered by Daiichi, which says it is planning to start clinical studies around March 2021 in collaboration with the University of Tokyo’s Institute of Medical Science.

VLP Therapeutics applied for the funding in response to an AMED request for proposals jointly with Japan’s National Center for Global Health and Medicine, the National Institutes of Biomedical Innovation, Health and Nutrition and two Japanese universities. The US-based venture’s vaccine is based on a proprietary platform the company says has been shown to induce neutralizing antibodies in animal studies within two weeks of dosing.

The support from AMED and other partners “will enable a very rapid development of this vaccine,” predicted VLP CEO Wataru Akahata. Set up in 2013, the company has developed virus-like particle and self-amplifying RNA vaccine vector technology for use in both infectious diseases and cancer. Its pipeline includes other candidates for malaria and dengue.

VLP says its inserted alphavirus virus-like particle platform, which displays disease-targeting epitopes on the surface of two alphaviruses (Chikungunya and Venezuelan equine encephalitis), can deliver substantial amounts of antigen on the surface of a virus to stimulate specific antibodies. The VLP platform allows expression of a virus’s core protein without any of the viral genome.

Janssen Starts Japan Trial With Ad26.COV2.S Vaccine

Janssen Pharmaceutical Cos. has started a Phase I clinical trial in Japan with its Ad26.COV2.S coronavirus vaccine candidate. The safety and immunogenicity study includes 250 healthy adults between the ages of 20 and 55 plus another group aged 65 and over, the firm’s local subsidiary said.

The adenovirus serotype 26 (Ad26) vector-based vaccine expressing the SARS-CoV-2 spike protein is already in Phase I/II studies in the US and Europe, with Phase III placebo-controlled studies expected to begin soon. These will investigate both a single- and double-dose regimen, and availability for emergency use seen in early 2021. (Also see "Coronavirus Update: J&J’s Single Dose Stands Out From COVID Vaccine Crowd" - Scrip, 31 Jul, 2020.)

Janssen has already reached a number of supply deals with governments and recently entered into a manufacturing alliance with Indian firm Biological E. Ltd. for 400-500 million doses annually. (Also see "J&J Taps Biological E For Up To 500m Coronavirus Vaccine Doses A Year" - Scrip, 14 Aug, 2020.)

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